Trimebutine on the Development of Adverse Events Related to the Helicobacter Pylori Eradication Medications

NCT ID: NCT04403087

Last Updated: 2022-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2021-07-01

Brief Summary

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Adverse events related to the eradication medication is one of the reason of lower eradication success in the H. pylori treatment. The aim of this study was to evaluate the additive effect of trimebutine for the development of adverse events related to the H. pylori eradication regimen.

Detailed Description

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Adverse events related to the eradication medication is one of the reason of lower eradication success in the H. pylori treatment. The common adverse events related to the eradication medications area as follows; Abdomen discomfort, pain, nausea, vomiting, diarrhea, bloating, urticaria, dizziness, headache, etc,. Various methods have been tried to reduce or prevent the adverse events related to the eradication medications. However, there is no established methods to reduce or prevent these events.

The aim of this study was to evaluate the additive effect of trimebutine for the development of adverse events related to the H. pylori eradication regimen.

Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trimebutine add group

Addition of Trimebutine on the Bismuth-containing quadruple regimen

Group Type EXPERIMENTAL

Trimebutine 100 MG

Intervention Type DRUG

Trimebutine 100mg three times a day

Control group

Bismuth-containing quadruple regimen

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Trimebutine 100 MG

Trimebutine 100mg three times a day

Intervention Type DRUG

Other Intervention Names

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Polybutine (Samil Pharm.Co.,Ltd.)

Eligibility Criteria

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Inclusion Criteria

* Subjects who underwent upper gastrointestinal endoscopy and were proven to have H. pylori infection either by using the rapid urease test, the 13 C-urea breath test (UBT), or histological examination.

Exclusion Criteria

* Subjects who took medications as Proton pump inhibitor, Histamin-2 receptor antagonist and antibiotics,
* Subjects who underwent stomach resection
* Subjects less than 18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chuncheon Sacred Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chang Seok Bang

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chang Seok Bang, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Hallym University

Locations

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Chuncheon Sacred Heart hospital

Chuncheon, Gangwon-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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BCSHPAE

Identifier Type: -

Identifier Source: org_study_id

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